Drug Type Small molecule drug |
Synonyms Acalabrutinib (JAN/USAN/INN), Acalabrutinib Maleate, Acalabrutinib Maleate Hydrate + [10] |
Target |
Action inhibitors |
Mechanism BTK inhibitors(Tyrosine-protein kinase BTK inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (31 Oct 2017), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China) |
Molecular FormulaC26H23N7O2 |
InChIKeyWDENQIQQYWYTPO-IBGZPJMESA-N |
CAS Registry1420477-60-6 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10893 | Acalabrutinib |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Mantle cell lymphoma recurrent | European Union | 27 May 2025 | |
Mantle cell lymphoma recurrent | Iceland | 27 May 2025 | |
Mantle cell lymphoma recurrent | Liechtenstein | 27 May 2025 | |
Mantle cell lymphoma recurrent | Norway | 27 May 2025 | |
Mantle cell lymphoma refractory | European Union | 27 May 2025 | |
Mantle cell lymphoma refractory | Iceland | 27 May 2025 | |
Mantle cell lymphoma refractory | Liechtenstein | 27 May 2025 | |
Mantle cell lymphoma refractory | Norway | 27 May 2025 | |
Small Lymphocytic Lymphoma | United States | 21 Nov 2019 | |
Chronic Lymphocytic Leukemia | Canada | 02 Oct 2019 | |
Mantle-Cell Lymphoma | United States | 31 Oct 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
ALK positive large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
Large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
Mediastinal large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type | Phase 3 | Germany | 07 Jun 2023 | |
T-cell/histiocyte rich large B-cell lymphoma | Phase 3 | Germany | 07 Jun 2023 | |
Recurrent Chronic Lymphoid Leukemia | Phase 3 | Germany | 19 Apr 2022 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | United States | 08 Oct 2020 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | China | 08 Oct 2020 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | Japan | 08 Oct 2020 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | Australia | 08 Oct 2020 |
Not Applicable | Chronic Lymphocytic Leukemia Bruton’s tyrosine kinase (BTK) inhibitor | - | Chemoimmunotherapy | zwlwcywmtj(btnfvwxwzm) = jxskmprwfq fmagfxprik (fkmmdueido ) | Positive | 30 May 2025 | |
Not Applicable | - | xejhevjvle(qdqnuhlljp): HR = 0.22 (95% CI, 0.09 - 0.53), P-Value = 0.001 View more | Positive | 30 May 2025 | |||
Not Applicable | 454 | kwmitnwxcs(wngvnteeeo) = less common with acalabrutinib than with ibrutinib ugtunebqmo (mthlwaiuar ) View more | Positive | 30 May 2025 | |||
Phase 2 | 44 | Venetoclax-acalabrutinib | ndosqabqew(ionolrrigx) = 50% cmsrnkaohp (qazojqmlvl ) View more | Positive | 14 May 2025 | ||
Phase 3 | Mantle-Cell Lymphoma blastoid/pleomorphic histology | - | Rituximab-Bendamustine | roxzmsjtiu(jcfholvuvf) = yvjmldqzvh ilqiiluhnh (arqbgjwfom ) View more | Positive | 14 May 2025 | |
Placebo+BR | roxzmsjtiu(jcfholvuvf) = ylxzxveeeu ilqiiluhnh (arqbgjwfom ) View more | ||||||
Phase 1 | Refractory Central Nervous System Lymphoma IRF4 mutation | 17 | Rituximab | eisfuxsgam(qkgeigzrkb) = Treatment-related adverse events occurred in 14 patients (82%), with 59% experiencing grade 3/4 events, mainly neutropenia, skin reactions, and transaminitis gvdokvvntm (jfofwucjvn ) | Positive | 14 May 2025 | |
Phase 3 | Mantle-Cell Lymphoma MRD positive | - | Bendamustine-Rituximab | mbaxtxxmqc(ueilmmagfy) = rmxeabvrxh spiegagmzl (msvrxhfsbz ) View more | Positive | 14 May 2025 | |
Placebo | mbaxtxxmqc(ueilmmagfy) = elmoqrlxqh spiegagmzl (msvrxhfsbz ) View more | ||||||
Phase 3 | 101 | R-miniCHOP | vhgvlzazll(gsduqhfcmh) = fyscjpvdar qgarodjqwa (pldmpzlzqm ) View more | Positive | 14 May 2025 | ||
R-miniCHOP + Acalabrutinib | vhgvlzazll(gsduqhfcmh) = svltygsilp qgarodjqwa (pldmpzlzqm ) View more | ||||||
Not Applicable | 454 | oodzbvhsat(kypoluprpy) = qchcjyvixr jouxicstps (qtpchpqgun ) View more | Positive | 14 May 2025 | |||
oodzbvhsat(kypoluprpy) = zmmlmglvcg jouxicstps (qtpchpqgun ) View more | |||||||
Phase 3 | 867 | Acalabrutinib-Venetoclax Combination | yzahtwcqfv(febzfoxfvb) = Death due to COVID-19 any time during the trial occurred in 10 (3.4%), 25 (8.7%), and 21 (7.2%) pts in the AV, AVO, and FCR/BR arms, respectively (of which 80.0%, 60.0%, and 33.3%, respectively, occurred during the tx-emergent period); 5/10, 9/25, and 7/21, respectively, were aged >65 y. edwnirutok (zmttiurckd ) | Positive | 14 May 2025 | ||